ONCOLYTICS BIOTECH INC. CALGARY, Nov. 5, 2015 /PRNewswire/ - Oncolytics Biotech(®) Inc. (TSX:ONC, OTCQX:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the third quarter ended September 30, 2015.
"During the quarter, we announced exciting initial clinical data from our multiple myeloma study showing statistically significant increases in the production of caspase-3 and upregulation of PD-L1 along with an early objective response rate of 100%," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also announced one and two-year survival data versus historical controls from our pancreatic (REO 017) cancer trial. This data is very often suggestive of broader immune system involvement which led us to file a US Phase 1b study in pancreatic adenocarcinoma; the first to examine REOLYSIN(®) in combination with the checkpoint inhibitor KEYTRUDA(®)."
Selected Highlights
Since July 1, 2015, selected highlights announced by the Company include:
Clinical Program
-- A poster presentation at the 15(th) International Myeloma Workshop
titled "Combination Carfilzomib and the Viral Oncolytic Agent
REOLYSIN(®) in Patients with Relapsed Multiple Myeloma: A Pilot Study
Investigating Viral Proliferation," highlighting data including 100% of
patients (8 of 8) experiencing an objective response as measured by
changes in blood monoclonal protein and significant increases in the
production of caspase-3 (p=0.005) and upregulation of PD-L1 (p=0.005);
-- An oral presentation at the International Association for the Study of
Lung Cancer (IASLC) 16(th) World Conference on Lung Cancer titled
"Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC
Patients with Ras Activated Malignancies, Long Term Results," covering
updated results, including one- and two-year survival data, from the
Company's REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC);
-- Presentation of final data from a single arm clinical study examining
the use of REOLYSIN(®) in combination with gemcitabine in patients with
advanced pancreatic cancer (REO 017), which showed an increase in median
overall survival, as well as an approximate two-fold increase in
one-year survival rates, and a five-fold increase in two-year survival
rates when compared to gemcitabine therapy alone as seen in historical
data;
-- Completion of enrollment in two randomized Phase 2 studies sponsored and
conducted by the NCIC Clinical Trials Group; IND 211 is a study of
REOLYSIN(®) in combination with chemotherapy in patients with
previously treated advanced or metastatic non-small cell lung cancer and
IND 209 is a study of REOLYSIN(®) in combination with chemotherapy in
patients with recurrent or metastatic castration resistant prostate
cancer;
-- Subsequent to quarter end, confirmation that, following submission to
the U.S. Food and Drug Administration ("FDA") for review, the
Investigational New Drug Application containing the protocol titled "A
Phase Ib study of pembrolizumab (KEYTRUDA(®)) in combination with
REOLYSIN(®) (pelareorep) and chemotherapy in patients with advanced
pancreatic adenocarcinoma", the Company's first trial examining REOLYSIN
in combination with a checkpoint inhibitor, was active; and
Financial
-- At September 30, 2015 the Company reported $30.0 million in cash, cash
equivalents and short-term investments. At November 5, 2015, the Company
had approximately $28.7 million in cash, cash equivalents and short-term
investments, which is expected to provide sufficient funds to support
several small early-stage immunotherapy combination studies as well as
both a run-in and a registration study in muscle invasive bladder
cancer.
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
September 30, December 31,
2015 2014
$ $
--- ---
Assets
Current assets
Cash and cash equivalents 27,962,462 14,152,825
Short-term investments 2,060,977 2,031,685
Accounts receivable 53,040 191,751
Prepaid expenses 480,611 291,553
---------------- ------- -------
Total current assets 30,557,090 16,667,814
-------------------- ---------- ----------
Non-current assets
Property and equipment 443,468 525,376
---------------------- ------- -------
Total non-current assets 443,468 525,376
------------------------ ------- -------
Total assets 31,000,558 17,193,190
============ ========== ==========
Liabilities And Shareholders' Equity
Current Liabilities
Accounts payable and accrued
liabilities 3,276,279 3,373,997
---------------------------- --------- ---------
Total current liabilities 3,276,279 3,373,997
------------------------- --------- ---------
Shareholders' equity
Share capital
Authorized:
unlimited
Issued:
September 30, 2015 -
117,981,672
December 31, 2014 - 93,512,494 261,229,719 237,657,056
Contributed surplus 26,029,865 25,848,429
Accumulated other comprehensive
income 657,103 280,043
Accumulated deficit (260,192,408) (249,966,335)
------------------- ------------ ------------
Total shareholders' equity 27,724,279 13,819,193
-------------------------- ---------- ----------
Total liabilities and equity 31,000,558 17,193,190
============================ ========== ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Three Nine Month Nine Month
Month Month Period Period
Period Period Ending Ending
Ending Ending September September
September September 30, 2015 30, 2014
30, 2015 30, 2014
$ $ $ $
=== === === ===
Expenses
Research and
development 1,704,784 3,571,939 6,601,877 11,305,328
Operating 1,176,023 1,105,274 3,780,812 3,706,343
--------- --------- --------- --------- ---------
Operating loss (2,880,807) (4,677,213) (10,382,689) (15,011,671)
Interest 52,756 39,937 153,313 178,177
-------- ------ ------ ------- -------
Loss before income taxes (2,828,051) (4,637,276) (10,229,376) (14,833,494)
Income tax
expense 4,074 668 3,303 (6,728)
----------- ----- --- ----- ------
Net loss (2,823,977) (4,636,608) (10,226,073) (14,840,222)
Other comprehensive income items that may be
reclassified to net loss
Translation
adjustment 192,586 100,461 377,060 108,442
------------ ------- ------- ------- -------
Net comprehensive loss (2,631,391) (4,536,147) (9,849,013) (14,731,780)
====================== ========== ========== ========== ===========
Basic and diluted loss per common
share (0.02) (0.05) (0.09) (0.17)
================================= ===== ===== ===== =====
Weighted average number of shares
(basic and 117,963,979 88,592,863 110,757,811 86,786,937
=========== ========== =========== ==========
diluted)
=======
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
Share Capital Contributed Warrants Accumulated Accumulated Total
Surplus Other Deficit
Comprehensive
Income
(Loss)
$ $ $ $ $ $
--- --- --- --- --- ---
As at December 31, 2013 228,612,564 24,491,212 376,892 79,698 (231,347,000) 22,213,366
Net loss and other comprehensive
income - - - 108,442 (14,840,222) (14,731,780)
Issued, pursuant to Share
Purchase Agreement 6,427,899 - - - - 6,427,899
Expired warrants - 376,892 (376,892) - - -
Share based compensation - 870,423 - - - 870,423
------------------------ --- ------- --- --- --- -------
As at September 30, 2014 235,040,463 25,738,527 - 188,140 (246,187,222) 14,779,908
======================== =========== ========== === ======= ============ ==========
Share Capital Contributed Warrants Accumulated Accumulated Total
Surplus Other Deficit
Comprehensive
Income
$ $ $ $ $ $
--- --- --- --- --- ---
As at December 31, 2014 237,657,056 25,848,429 - 280,043 (249,966,335 13,819,193
Net loss and other comprehensive
income - - - 377,060 (10,226,073) (9,849,013)
Issued, pursuant to Share
Purchase Agreement 4,305,396 - - - - 4,305,396
Issued, pursuant to "At the Market"
Agreement 19,267,267 - - - - 19,267,267
Share based compensation - 181,436 - - - 181,436
------------------------ --- ------- --- --- --- -------
As at September 30, 2015 261,229,719 26,029,865 - 657,103 (260,192,408) 27,724,279
======================== =========== ========== === ======= ============ ==========
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Three Nine Nine
Month Month Month Month
Period Period Period Period
Ending Ending Ending Ending
September September September September
30, 2015 30, 2014 30, 2015 30, 2014
$ $ $ $
--- --- --- ---
Operating Activities
Net loss for the period (2,823,977) (4,636,608) (10,226,073) (14,840,222)
Amortization -property and
equipment 44,761 39,904 134,743 118,073
Share based compensation 10,791 199,821 181,436 870,423
Unrealized foreign exchange loss
(gain) (182,131) 243,290 (485,653) 193,301
Net change in non-cash working
capital 92,792 (261,622) (327,690) (2,701,103)
------------------------------ ------ -------- -------- ----------
Cash used in operating activities (2,857,764) (4,415,215) (10,723,237) (16,359,528)
--------------------------------- ---------- ---------- ----------- -----------
Investing Activities
Acquisition of property and
equipment (17,695) (113,782) (47,292) (131,001)
Purchase of short-term investments - - (29,292) (30,041)
---------------------------------- --- --- ------- -------
Cash used in investing activities (17,695) (113,782) (76,584) (161,042)
--------------------------------- ------- -------- ------- --------
Financing Activities
Proceeds from Share Purchase
Agreement - 2,736,749 4,305,396 6,427,899
Proceeds from "At the Market" equity distribution
agreement 213,742 - 19,267,267 -
--------- ------- --- ---------- ---
Cash provided by financing
activities 213,742 2,736,749 23,572,663 6,427,899
-------------------------- ------- --------- ---------- ---------
Increase in cash (2,661,717) (1,792,248) 12,772,842 (10,092,671)
Cash and cash equivalents,
beginning of period 30,018,217 16,880,730 14,152,825 25,220,328
Impact of foreign exchange on cash and cash
equivalents 605,962 (75,514) 1,036,795 (114,689)
----------- ------- ------- --------- --------
Cash and cash equivalents, end of
period 27,962,462 15,012,968 27,962,462 15,012,968
================================= ========== ========== ========== ==========
To view the Company's Fiscal 2015 Third Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual filings, which will be available on www.sedar.com and on www.oncolyticsbiotech.com/for-investors/financials.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN(®), its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's belief as to the potential of REOLYSIN(®) as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2015 and beyond, the Company's planned operations, the value of the additional patents and intellectual property; the Company's expectations related to the applications of the patented technology; the Company's expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN(®) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN(®), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.
